CRA I - Senior CRA (FSP)
Core
Conducts remote and on-site clinical monitoring of investigator sites to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/medical device sponsors
Domain
Clinical Research / Life Sciences / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, critical thinking, ICH-GCP knowledge, therapeutic area knowledge (Oncology), site initiation and close-out, regulatory compliance, data review (SDR/SDV/CRF), investigator management
Preferred skills
Registered Nursing certification, PPD Drug Development Fellowship, advanced digital literacy, presentation skills
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify failures and implement corrective actions; Conduct on-site and remote monitoring activities including data review and inventory checks; Initiate and close out clinical trial sites in collaboration with clients; Ensure audit readiness and maintain required documentation; Facilitate communication between sites, clients, and project teams; Track trial status and provide progress reports to management.
Seniority
Senior, hands-on IC
